Medical Device Definition Under Article 25

1. Key takeaways

The definition of a medical device in Honduras appears in Article 25 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario: devices are instruments, apparatuses, machines, software (softwares), biomedical equipment, in vitro diagnostic devices (IVD), medical solutions or other similar or related items, used alone or in combination, including components and accessories that affect their proper use; their principal intended action must not be achieved by pharmacological, immunological or metabolic means, although they may be assisted by such means. The provision lists 8 intended purposes: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, prevention, monitoring, treatment, alleviation of or compensation for injury or disability; investigation, replacement, modification or support of anatomy or physiological processes; diagnosis of pregnancy and contraception; sustaining or supporting life; care during pregnancy, childbirth and the postnatal period, including newborns; disinfection and/or sterilisation of other devices; and disinfecting, antibacterial, skin-filling, lubricating and decongestant solutions that contain no active ingredient and act only locally.

• Software is expressly written into the definition, the largest departure from the old framing; filing a software product as a non-device leads to rejection at classification.
• Where an assessment concludes that a product is in fact a medicine, Article 48 transfers it to the DNPF.
• IVD extra documents appear in two places, Article 32 item 6 and Article 43 section 2, and the lists are not identical.

2. Legal basis

The provisions governing definition and routing are the following.

3. Expert insights

Insight 1: the clause that the principal action is not achieved by pharmacological, immunological or metabolic means is the triage gate. Article 25 uses this sentence to separate devices from medicines, and Article 48 supplies the enforcement mechanism: where ARSA concludes during a modification assessment that the purpose of a device is in fact medicinal, it transfers the file to the DNPF and must notify the applicant. For drug-device combinations, drug-coated devices and some skin-filling products, this means the qualitative conclusion is not decided unilaterally by the company: the pharmacological mechanism statement submitted becomes evidence of classification, so wording must be handled carefully.

Insight 2: software is inside the definition, but extra documents attach only at higher risk classes. Article 25 writes software into the definition, while Article 44 item 4 adds 7 documents for Clase IIA medical computer systems (component diagrams, a technical design report, reports on cybersecurity and information storage and communication, verification and validation test reports, version and defect history, a description of the current version, and clinical evaluation studies). In other words, a Clase I software product attracts no extra software-specific documents; Clase IIA and above do. When budgeting for software products, classify first and then estimate the document load; do not assume that software is always harder.

Insight 3: IVD is named inside the definition, yet its documents sit in two places. Article 25 places IVD within the device definition, but the additional IVD documents appear once in Article 32 item 6 (classification report stage) and once in Article 43 section 2 (registration stage), and the two lists are not identical. The classification stage requires the safety data sheet and the qualitative and quantitative formulation with CAS numbers, while the registration stage also requires technical documents supporting shelf life or stability. Both sets must be prepared; submitting only one is not enough.

Insight 4: the eighth purpose brings locally acting solutions without active ingredients into the device regime. Disinfecting, antibacterial, skin-filling, lubricating and decongestant solutions are regulated as devices so long as they contain no active ingredient and act only locally. Article 43 section 3 lists a separate set of 7 documents for them, including sterilisation certificates, container-sealing technical documents and a product effectiveness validation report. Such products are often wrongly filed as cosmetics or disinfectant products, which makes this a frequent rejection point in this market.

Insight 5: other devices of sanitary interest are the third route. The final paragraph of Article 25 lists food and drinking-water quality control items, laboratory water quality control devices, and devices used only for research and forensic purposes as other devices of sanitary interest. They do not undergo sanitary registration and instead follow the import permits of Articles 54 and 55 (RUIF and NTDM). The test is whether the product falls within a risk class: those that do not take the third route, those that do take registration.

4. Practical recommendations

• For products containing drugs, biological components or drug coatings, prepare a statement of the principal mechanism of action showing that it does not depend on pharmacological, immunological or metabolic means, and submit it with the dossier as classification evidence.
• Classify software products first and estimate documents by class: Clase I adds no software-specific documents, Clase IIA and above add 7.
• Prepare both document lists for IVD, at the classification report stage and the registration stage, deduplicate and merge them, and never submit only one set.
• File disinfecting, antibacterial and skin-filling products as devices, and reserve time for the effectiveness validation report and container-sealing technical documents.
• For products that genuinely test water or food, or are for research and forensic use only, switch to the RUIF and NTDM route instead of a registration dossier.
• Add a column to the internal product classification table recording whether the product falls within a risk class, as the switch between registration and the third route.

5. Verification checklist

• □ The product has been compared item by item against the Article 25 definition
• □ Products with drug or biological components have a statement of the principal mechanism of action
• □ Software products have been risk classified, with the 7 extra documents confirmed or excluded by class
• □ IVD dossiers contain both the Article 32 item 6 and the Article 43 section 2 document sets
• □ Disinfecting and antibacterial products have the effectiveness validation report and container-sealing technical documents
• □ Water and food testing products and research-only products have switched to the RUIF or NTDM route

Regulatory information verified as of 2026-10-29.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Honduran market. Our team manages Secretariat of Health (SESAL) registration applications through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com